Regulatory Milestone: Subsidiary of Aurisco Pharmaceutical Passes U.S. FDA Inspection

Stock News

Aug 12

Aurisco Pharmaceutical Co.,Ltd. (605116.SH) announced that its wholly-owned subsidiary, Yangzhou Aurisco Pharmaceutical Co., Ltd. ("Yangzhou Aurisco"), underwent a cGMP (Current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration (FDA) from June 15 to 19, 2026.

Recently, Yangzhou Aurisco received a notification letter and the on-site inspection report issued by the FDA for this inspection. The notice indicates that Yangzhou Aurisco's quality management system meets the U.S. FDA standards, successfully passing the FDA's pre-approval inspection and routine GMP compliance inspection for marketed products.

The inspection scope included products such as Inclisiran sodium, Semaglutide, Coratrone, and Brivaracetam.

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(\"Yangzhou Aurisco\"), underwent a cGMP (Current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration (FDA) from June 15 to 19, 2026.<br><br>Recently, Yangzhou Aurisco received a notification letter and the on-site inspection report issued by the FDA for this inspection. 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